Vessel Sealing Device with Automatic Deployment

ABSTRACT

A device and a method for sealing an opening in the wall of a blood vessel is provided. The device includes an automatic mechanism, a shaft fixedly connected to the automatic mechanism, a seal assembly attached to the distal end of the shaft, and a pushing rod also engaging the seal assembly, the automatic mechanism moving the pushing rod from a first position to a second position in response to the shaft being pulled distally a predetermined distance.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to a sealing device for theclosure of puncture holes in blood vessels and, in particular, to asealing device that does not require a sheath change and is simple withan automatic feature.

2. Technical Background

For many diagnostic and interventional procedures it is necessary toaccess arteries or veins. Vessel access is accomplished either by directvision or percutaneously. In either case, the target vessel is puncturedwith a hollow needle containing a tracer wire. When the intravascularpositioning of the tracer wire has been verified, the hollow needle isremoved leaving the tracer wire. Next, a sheath containing a dilator ispushed in over the tracer wire. The dilator enlarges the punctureopening to facilitate the insertion of the larger diameter sheath intothe blood vessel. The sheath usually consists of a hollow tube with anopen distal end and a hemostatic valve at a proximal end, which remainsoutside the body and blood vessel. The hemostatic valve is made of acompliant material and is designed in such a way as to allow devicessuch as catheters to be inserted and withdrawn from the blood vesselwith minimal blood loss. After the sheath has been inserted into theblood vessel, the dilator is removed leaving a clear passageway in thesheath for the catheter. The sheath is removed from the blood vesselafter the procedure is finished resulting in bleeding at the puncturesite that must be staunched.

Traditionally, pressure is applied to the puncture site to allow timefor the blood to clot thereby stopping the bleeding. Depending on theamount of anticoagulants that may have been administered to the patientduring and prior to the procedure, the time pressure must be maintainedvaries from 15 minutes to more than an hour. Once bleeding has stopped,a pressure bandage is placed over the site of the puncture in an attemptto protect the integrity of the clot. The pressure bandage must remainin place for some time, usually from 8 to 24 hours. During this periodof time the patient must remain in bed, sometimes requiring an overnighthospital stay.

To shorten the length of time required for the patient to becomeambulatory and to lessen complications sometimes arising from thetraditional method, several closure devices have been developed. Onesuch device, as described in U.S. Pat. No. 5,620,461, a foldable sheetwith an attachment thread is inserted into the opening in the bloodvessel and an arresting element is applied over the attachment elementagainst the outside of the blood vessel. Another such device isdescribed in U.S. Pat. Nos. 6,045,569 and 6,090,130, and includes anabsorbable collagen plug cinched down against an absorbableintervascular anchor via an absorbable suture. The anchor has anelongated rectangular shape that requires it to be inserted into thepuncture wound with its longitudinal axis parallel to the sheath axis.This requires it to be rotated ninety degrees after insertion so thatblood flow obstruction is minimized. A specially designed sheath isnecessary to assure proper rotation, thus resulting in an otherwiseunnecessary sheath change. The long dimension of the anchor is thuslarger than the cannula inside diameter (ID) and the width is smallerthan the ID. The collagen plug is in an elongated state prior todeployment and is forced into a ball shape via a slipknot in the suture,which passes through the collagen, and a tamper that applies a distalforce to it. The anchor acts as a support for the suture cinch whichforces the collagen ball shape up against the exterior vessel wall andthe anchor. Blood flow escaping around the anchor is slowed down andabsorbed by the collagen material and thus forms a clotting amalgamationoutside the blood vessel that is more stable than the traditional methodof a standalone clot. The added robustness of the amalgamation clotallows earlier ambulation of the patient.

The device raises several issues. It is not a true sealing device butrather a clotting enhancement device, as opposed to a device with twoflat surfaces exerting sealing pressure on both the interior andexterior of the blood vessel, a much more reliable technique. In eithercase bleeding occurs during the time between removal of the sheath andfull functionality of the deployed device. Thus “instant” sealingpressure from two flat surfaces is desirable over a method that reliesto any extent on clotting time. One such device is disclosed by Bateset. al. in U.S. Pat. No. 8,080,034. The '034 device comprises aninternal sealing surface pivoting on a rigid post to accommodate thelongitudinal dimension of the seal inside the sheath ID. The exteriorseal (second clamping member) is slidable along the rigid post andpivotal such that it, along with the internal seal, sandwiches the wallof the blood vessel via a locking ratchet. One problem with this designis that the pivoting feature increases the cross-sectional dimension ofthe seal thus requiring a larger diameter sheath than would be otherwiseneeded. In addition, the pivoting internal seal has no means to assurethat the seal pivots to the correct sealing position as the ratchetcloses. This could cause the internal seal to exit the blood vessel inthe collapsed configuration as the user withdraws the deploying device.

The seals are release by the user cutting the suture thread in thedevice described in U.S. Pat. No. 6,045,569.

It is known that the opening in the blood vessel closes to some extentafter the sheath is removed thus allowing smaller seal surfaces thanwould otherwise be required. What is less known is that the opening doesnot close as quickly as a truly elastic material such as natural rubber.For this reason seal surfaces of closure devices that are activated inless than a second, or perhaps even longer, after sheath removal must bephysically larger than the sheath outside diameter to avoid embolizationof the seals because of the delayed vessel closure. The design of sealsthat are deployed through a sheath ID with dimensions larger than thesheath OD upon deployment is a challenge since the preferred materialfor seals are bio-absorbable and thus have limited mechanicalproperties.

The '569 device requires removing the catheter sheath and replacing itwith a custom sheath prior to deployment, resulting in addition bloodloss. The tamping force used to deploy the collagen against the anchoris left to the surgeon's feel sometimes resulting in inadequatedeployment and other times resulting in the collagen being pushedthrough the puncture wound, into the blood vessel along with the anchor.Inadequate tamping results in excessive bleeding with the potential forpainful hematoma and over tamping can result in a surgical procedure toremove the device from the blood vessel lumen. In addition, theabsorption rate of the suture, the collagen, and the anchor may bedifferent owing to the fact that they are formed from differentmaterials, sometimes resulting in the detachment of the anchor, whichcan move freely in the blood stream and become lodged in the lowerextremities of the body, again requiring surgical removal.

It is worth noting that the prior art device, U.S. Pat. No. 6,045,569,relies on clotting and is not a true vessel seal. U.S. PatentApplication 20060265007 discloses an automatic tamping system that isusable on devices such as those described in U.S. Pat. Nos. 6,045,569and 6,090,130, to automate certain aspects of deployment but it fails toprovide a means for detecting the artery wall. Automatically deploymentrequires detection of the seal against the artery wall to avoid earlydeployment and potential embolization. The lack of such automation cancause deployment errors that result in bleeding and other seriousevents. In addition the '569 device requires 11 steps to completehemostasis requiring 4-10 minutes of valuable facility and staff time.

It would be desirable therefore to provide a vessel-sealing device thatactually seals the blood vessel and does not rely on the clotting of theblood. It is also desirable to provide a closure device that isdeployable through the catheter sheath with minimal steps requiring lessthan 2 minutes for hemostasis. It would be also desirable to provide areliable vessel-sealing device the deployment efficacy of which isindependent of the surgeon's feel, i.e. automatic deployment andautomatic release of the seals from the deployment instrument.

SUMMARY OF THE INVENTION

The present invention is directed to a device for sealing an opening inthe wall of a blood vessel, the blood vessel having an interior wallsurface, exterior wall surface, and a lumen, the device includes anautomatic mechanism, a shaft extending between a proximal end and adistal end, the shaft being fixedly connected to the automaticmechanism, a seal assembly having a first portion and a second portion,the seal assembly operatively attached at the first portion to thedistal end of the shaft, the seal assembly configured to engage theinterior wall surface and the exterior wall surface of the blood vessel,and a pushing rod operatively engaging the seal assembly at the secondportion and movable relative to the shaft, the automatic mechanismmoving the pushing rod from a first position to a second position inresponse to the shaft being pulled distally a predetermined distance.

In some embodiments, the device also includes a safety latch, the safetylatch movable between a first position and a second position, the safetylatch engaging a pusher of the automatic mechanism in the first positionthereby preventing the pusher from moving the pushing rod.

In some embodiments, the automatic mechanism includes a pusher, thepusher moving the pushing rod from a first position to a second positionin response to the shaft being pulled distally a predetermined distance.

In some embodiments, the automatic mechanism includes a shaft retainingelement fixedly attached to the shaft, a pusher, the pusher fixedlyattached to the pushing rod, a spring, a spring retainer, the springbiased against at least one surface of the spring retainer, and at leastone retention element rotatably movable between a first and secondposition, the at least one retention element disposed adjacent thespring retainer and engages the spring retainer in the first position.

In some embodiments, the shaft pulls the shaft retaining elementdistally, allowing the spring retainer to rotate the at least oneretaining element and engage the pusher to move the pusher distally.

The present invention is also directed to a device for sealing anopening in the wall of a blood vessel, the blood vessel having aninterior wall surface, exterior wall surface, and a lumen, the deviceincludes an automatic mechanism comprising a shaft retaining element, apusher, a spring retainer, a spring biased against at least one surfaceof the spring retainer, at least one retention element rotatably movablebetween a first and second position, the at least one retention elementdisposed adjacent the spring retainer and engages the spring retainer inthe first position, a shaft extending between a proximal end and adistal end, the shaft being fixedly connected to the shaft retainingelement, a seal assembly having a first portion and a second portion,the seal assembly operatively attached at the first portion to thedistal end of the shaft, the seal assembly configured to engage theinterior wall surface and the exterior wall surface of the blood vessel,and a pushing rod fixedly attached to the pusher and movable relative tothe shaft, the pushing rod operatively engaging the seal assembly at thesecond portion, the pusher moving the pushing rod from a first positionto a second position in response to the shaft being pulled distally apredetermined distance.

In yet another aspect, the present invention is directed to a method ofsealing an opening in the wall of a blood vessel, the blood vesselhaving an interior wall surface, exterior wall surface, and a lumen, themethod includes inserting at least a portion of a distal end of anautomatic device through the opening and into the lumen, the distal endhaving a seal assembly that includes a first sealing element disposed inthe lumen of the blood vessel and configured to engage the interior wallsurface and a second sealing element to engage the exterior wallsurface, pulling proximally on the automatic device, causing the firstsealing element to engage the interior wall surface and pull on a shaftconnected to the seal assembly, thereby causing the automatic device toautomatically push the second sealing element against the exterior wallsurface sealing the opening in the wall of the blood vessel, andremoving automatic device leaving only the seal assembly behind.

Additional features and advantages of the invention will be set forth inthe detailed description which follows, and in part will be readilyapparent to those skilled in the art from that description or recognizedby practicing the invention as described herein, including the detaileddescription which follows, the claims, as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description of the present embodiments of theinvention, and are intended to provide an overview or framework forunderstanding the nature and character of the invention as it isclaimed. The accompanying drawings are included to provide a furtherunderstanding of the invention, and are incorporated into and constitutea part of this specification. The drawings illustrate variousembodiments of the invention and together with the description serve toexplain the principles and operations of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a sealing deviceaccording to the present invention;

FIG. 2 is a perspective view of a portion of the sealing device of FIG.1 illustrating the seal assembly thereof;

FIG. 3A is a side plan view of the first sealing element and the shaft;

FIG. 3B is a bottom plan view of the first sealing element and theshaft;

FIG. 4A is a cross section view along a longitudinal axis of a secondsealing element of the seal assembly of FIG. 2;

FIG. 4B is a cross section view of the second sealing element of theseal assembly of FIG. 2 that is orthogonal to the view in FIG. 2;

FIG. 5A is a perspective view of a sheath introducer used with thesealing device of FIG. 1;

FIG. 5B is an exploded, perspective view of the sheath introducer ofFIG. 5A;

FIG. 6 is a cross section view of the seal assembly constrained in asheath introducer;

FIG. 7 is a front perspective view of the sealing device with the tophandle half removed;

FIG. 8 is a perspective partial view of the safety latch;

FIG. 9 is an exploded view of the sealing device of FIG. 1;

FIG. 10 is a cross section view of the sealing device of FIG. 1 alongthe longitudinal axis;

FIG. 11 is an enlarged, partial cross section view of the sealing deviceof FIG. 1;

FIG. 12 is a top view of the sealing device of FIG. 1 with the top halfof the handle and safety latch removed in a pre-insertion configuration;

FIG. 13 is a top view of the sealing device of FIG. 1 with the top halfof the handle and safety latch removed in a post-firing configuration;

FIG. 14 is a perspective view of the sealing device inserted into ablood vessel;

FIG. 15 is partial cross section view of a blood vessel with the sealingdevice inserted therein;

FIG. 16 is perspective view of the sealing device inserted into theblood vessel just before the sealing device is activated; and

FIG. 17 is a perspective view of the seal assembly blocking the openingin the blood vessel after activation of the sealing device;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferredembodiment(s) of the invention, examples of which are illustrated in theaccompanying drawings. Whenever possible, the same reference numeralswill be used throughout the drawings to refer to the same or like parts.

Referring to FIGS. 1 and 2, closure device 10 is illustrated as havingtwo handle halves 12,14 that house an automatic mechanism, described inmore detail below, which is coupled to the seal assembly 20 by aflexible pusher rod 16 and a flexible shaft 18. See FIG. 6. The sealassembly will be described briefly here, but is the subject ofco-pending application titled “Improved Vessel Seal Device,” assignedAtty Docket SHJO-016 and assigned Ser. No. 13/______, the contents ofwhich are incorporated herein by reference in their entirety. Sealassembly 20 has a first sealing element 22, a knobbed rigid shaft 24, anouter floating element 26, and a second sealing element 28. Knobbed,rigid shaft 24 has a proximal section 30 and a distal section 32separated by a weakened notch feature 34, which is configured toseparate seal assembly 20 from the rest of the closure device 10 oncethe automatic deployment and sealing process is complete. The length ofthe distal section 32 of knobbed shaft 24 is dictated by the thicknessof the blood vessel wall that can be accommodated. See FIG. 15. Thefirst sealing element 22 also has a distal section 40 configured tointerface with the inside wall of a vessel to be sealed, a knobbed,rigid distal shaft section 32 (which is a part of the knobbed, rigidshaft 24), and ankle section 42 joining the distal section 40 to theknobbed, rigid distal shaft section 32. The ankle section 42 is attachedto distal section 40 at an angle α, which is preferably at an angle ofabout 45°. Although other angles may be used, the value of angle α maycause other values of the seal assembly to be changed, as discussed indetail below.

More detailed views of the first sealing element 22 and the knobbedrigid shaft 24 are illustrated in FIGS. 3A-3B. The first sealing element22 has the distal section 40, ankle section 42 and the knobbed, rigiddistal shaft section 32. The distal section 40 has a proximal or topsurface 50, a bottom surface 52 and an outer peripheral surface 56. Theproximal or top surface 50 is preferably configured to engage theinterior wall surface 142 of the blood vessel 140 (see FIG. 15), whichmeans that the top surface 50 is preferably flat. However, the topsurface 50 can be of any configuration (e.g., flat, convex, etc) andstill come within the scope of the present invention. The bottom surface52 is preferably flat, but may have other configurations. As notedbelow, the exact configuration of the surfaces 50,52 may also depend onthe strain that is placed on them prior to and during insertion. Theouter peripheral surface 56 is preferably continuous in that it has nodiscontinuities. That is, the outer peripheral surface 56 is smooth andhas no sharp angles (e.g., 30, 45 or 90° angles). Since the distalsection 40 is to be deformed prior to insertion into the blood vessel140, any sharp angles tend to create stress points, potentially causingthe distal section 40 to be bent/deflected beyond its ability to returnto its original configuration. The distal section 40 has a thicknessthat increases from the front (or distal) end 58 to the rear (orproximal) end 60. In the embodiment illustrated in the figures, thethickness increases from 0.28 mm at the front end 58 to 0.30 mm at therear end 60. However, other thicknesses and tapered shapes fall withinthe scope of the present invention.

Second sealing element 28 is shown in more detail in FIGS. 4A and 4B.The second sealing element 28 has a proximally facing surface 80 and asloped distally facing surface 82. An internal opening 84 defined by theinternal surface 86 extends between the proximally facing surface 80 andthe sloped distally facing surface 82. The internal surface 86 hasextending therefrom and into the internal opening 84 projections 88 thatinterface with and engage the knobs 62 with an interference fit suchthat second sealing element 28 and knobbed rigid shaft 24 function as aone way latch assuring an adequate compression force regardless of theblood vessel wall thickness.

The internal opening 84 of second sealing element 28 (and floating foot26) have two flat surfaces 90 on opposite sides of the internal opening84 that interface with flat surfaces 68,70 of knobbed rigid shaft 24 toprovide rotational stability of the seal assembly components 26,28 thusassuring that the sloped distally facing surface 82 and the fullydeployed floating foot 26 remain parallel with the distal section 40 ofthe first sealing element 22 and the proximal or top surface 50 inparticular.

FIGS. 5A and 6B depict introducer or outer sleeve 100, which isconfigured to protect seal assembly 20 from damage when inserting sealassembly 20 through a hemostatic valve, which, as discussed below and inmore detail in the co-pending application, is one method in which theseal assembly is inserted into the patient. Introducer 100 comprises twohalves, 102,104, which when assembled together form a generallycylindrical body having two different diameters. Front section 106 ofintroducer 100 has a smaller diameter than rear section 108. Frontsection 106 with the smaller diameter is configured to be inserted intohemostatic valve and rear section 108, having the larger diameterremains proximal to the hemostatic valve. While the two halves 102,104can be assembled according to any typical manner, pins 110 on one of thetwo halves 102,104 are configured with a press fit into correspondingmating holes 112 thus holding halves 102,104 firmly together.

The introducer 100 has an opening 114 that extends between the frontsection 106 and the rear section 108. However, within the opening 114are also grooves 116 that are configured to accept seal assembly 20. Theopening 114 is also configured to receive at least a portion of pusher16 of the seal device 10. FIG. 6 is a cross section of seal assembly 20in the initial position inside introducer 100 prior to insertion into asheath 120. See FIG. 8. The front end 58 and the rear end 60 of thedistal portion 40 of first sealing element 22 are deformed into aconfiguration such that the distal portion 40 of first sealing element22 is able to pass through the inside dimension of cannula 122 uponinsertion of closure device 10 resulting in the configuration shown inFIG. 6. After exit from distal end of cannula 122, the front end 58 andthe rear end 60 of the distal portion 40 of first sealing element 22return to the initial configuration as shown in FIG. 2 owing to theconfiguration shown in FIG. 6 not exceeding the elastic limit of thematerial from which the seal assembly 20 is constructed.

Turning now to the main portion of the closure device 10 and referringto FIGS. 7-13, closure device 10 comprises two handle halves 12, 14 thathousing automatic mechanism 150. The automatic mechanism 150 interfaceswith safety latch 152, which has a safety slide 154 that interacts withsafety cage 156 via pin 158. The safety latch 152 operates such thatwith safety slide 154 in the distal most position automatic mechanism150 cannot be activated. The proximal most position of safety slide 154allows automatic activation, explained in more detail below. The pin 158is in the center of the underside of safety slide 154 and passes throughhandle opening 160 of handle half 12 and engages slot 162 of safety cage156. With the safety slide 154 in the full distal position, the pin 158forces safety cage 156 into the position shown in FIG. 7 (to the leftlooking distally) such that leg 164 is forced into a slot 166 in pusher170 that locks the movable pusher 170 against distal movement. Themovement of the other parts of the automatic mechanism 150 are discussedin more detail below. In this position, safety slide 154 covers the word“READY” (or any other word, mark or appropriate indicia) and exposes theword “SAFE” (or any other word, mark or appropriate indicia) embossed onhandle half 12. In this position, the safety latch 152 prevents theautomatic mechanism 150 from premature firing during shipment orhandling. With safety slide 154 in the proximal-most position, the pin158 forces safety slide 154 to the right, thus removing leg 164 from theslot 166 in pusher 170. In this position the automatic mechanism 150 isfree to initiate when first sealing element 22 interacts with the insideof vessel wall 142. In this configuration safety slide 154 covers theword “SAFE” and exposes the word “READY” on handle half 12.

Flexible pusher rod 16 is a cannulated cylinder, the proximal end ofwhich is connected by an adhesive or by another appropriate method tothe movable pusher 170. The movable pusher 170 has a front portion 172with an opening 174 for engagement with the flexible pusher rod 16 andto allow the flexible shaft 18 to pass through front portion 172. Thepusher 170 also has a rear portion 176 that is divided into an upperportion 176 a and a lower portion 176 b, the upper portion 176 a and alower portion 176 b defining an opening 178 therebetween.

The automatic mechanism 150 also includes a shaft retaining element 180that, in the initial or preactivation stage, is disposed in opening 178defined by the upper portion 176 a and a lower portion 176 b of pusher170. The shaft retaining element 180 also has an opening 182 passingtherethrough to allow the flexible shaft 18 to pass therethrough andextend proximally in the automatic mechanism 150. However, the flexibleshaft 18 is fixedly attached to the shaft retaining element 180. Theflexible shaft 18 therefore extends almost the entire length of thedevice 10. As noted above, the flexible shaft 18 is also connected tothe knobbed rigid shaft 24 of the seal assembly 20. As explained below,a tensile force on the flexible shaft 18 causes the automatic mechanism150 to fire.

The automatic mechanism 150 also has a spring 190, which is illustratedas a cylindrical spring, but could be any resilient element and have anyconfiguration. The spring 190 engages, at its proximal end, the proximalend of the handle 12,14. The spring 190 is disposed around a springretainer 194 and engages at its distal end, the front end 196 of thespring retainer 194. The spring 190 is biased against the front end 196of the spring retainer 194 to push the spring retainer 194 against thepusher 170, as described in more detail below.

The automatic mechanism 150 also has two retention elements 200 that arerotatably mounted in the housing 12,14. The two retention elements 200are illustrated as being generally triangular, but could be of any shapeor configuration as long as they perform the functions noted below. Theretention elements 200 are disposed to engage the front end 196 of thespring retainer 194 and the shaft retaining element 180. In fact, eachof the two retention elements 200 engage a notch 202 on either side ofthe shaft retaining element 180. The retention elements 200 each have anend portion 204, preferably a flat surface, that engages an internalsurface of the notches 202. As can best be seen in FIG. 9, the retentionelements 200 are disposed on round projections 206 extending upward fromthe handle 14. The projections 206 could also project downward from thehandle 12.

The use of the device 10 will now be described in conjunction with FIGS.12-17. FIGS. 12 and 13 are top views of the device with the upper handlehalf 12 and the safety latch 152 removed for clarity and to showpre-firing and post-firing, respectively. In FIG. 12, the spring 190 iscompressed by spring retainer 194, which when released will provide thekinetic energy to seal the opening in the blood vessel and to break theknobbed rigid shaft 24. The spring retainer 194, and in particular thefront end 196, is biased against the retention elements 200. Theretention elements 200 can not move due to the end portion 204 engagingthe internal surface of the notches 202 of the shaft retaining element180. The front end 196 of spring retainer 194 is separated from thepusher 170 by the retention elements 200. Keeping in mind that the shaftretaining element 180 is secured to the flexible shaft 18, which in turnis secured to the knobbed rigid shaft 24, pulling on the seal assembly20 will cause the flexible shaft 18 to be pulled distally and move shaftretaining element 180 distally as well. This allows the retentionelements 200 to rotate outward given the biasing of the front end 196 ofthe spring retainer 194. The front end 196 of the spring retainer 194can then push pusher 170 connected to the flexible pusher rod 16distally. The effect of this movement is illustrated in FIG. 13.

A method of using the current invention in conjunction with FIGS. 14-17is as follows: The device 10, and in particular the seal assembly 20 isinserted into sheath introducer 100 that surrounds and deforms sealassembly 20 such that seal assembly seal 20 can pass through sheathvalve 132. See also FIG. 6. The device 10 and sheath introducer 100 isinserted into a hemostatic valve for insertion into the patient. Thedevice 10 preferably has a latch 210 that can be used to attach thedevice 10 to the sheath 120. This allows for the simultaneous removal ofthe device 10 and the sheath 120, if the sheath is not removed prior tothe activation of the automatic mechanism 150. Inserting pusher 16through sheath 120, including valve 132 and cannula 122, causes at leasta portion of seal assembly 20 to exit the distal end of cannula 122 andinto blood vessel 140. See FIG. 14. A portion of the second sealingelement 28 and the pusher 16 may be disposed within the blood vessel140. See FIG. 15. The sheath 120 may then be removed from the device 10.Pulling on the closure device 10, the proximal or top surface 50 of thedistal portion 40 of first sealing element 22 engages the interior bloodvessel wall 142. See FIG. 16. This would also remove the second sealingelement 28, the outer floating element 26, and the pusher 16 from withinthe blood vessel 140. Continuing to pull on the sealing assembly 20 andtherefore flexible shaft 18 triggers the automatic mechanism 150 in theclosure device 10, which pushes pusher 16, and which in turn pushessecond sealing element 28, and floating foot 26 distally such thatfloating foot 26 is in contact with outer wall of blood vessel 140. Thiswill sandwich the second sealing element 28 against floating foot 26,blood vessel 140 and distal portion 40 of first sealing element 22 suchthat the opening in blood vessel 140 is hemostatically sealed, as shownin FIG. 17.

The initial spring compression is chosen such that accounting forfriction losses the remaining kinetic energy is sufficient to breakweakened notch feature 34 of knobbed rigid shaft 24 resulting in thedistal truncated portion of seal assembly 20 becoming detached from therest of closure device 10 and also providing vessel hemostasis as shownin FIG. 17. Note that as the user moves sheath 120 and closure device 10proximally activating the automatic process and removes the two latchedcomponents, the handle and the sheath, from the body nothing remains inthe patient except the bio-absorbable truncated portion of seal assembly20. Thus the entire closure process of sealing and disconnection isautomatic requiring no “tactical feel” of the user.

It will be apparent to those skilled in the art that variousmodifications and variations can be made to the present inventionwithout departing from the spirit and scope of the invention. Thus, itis intended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

I claim:
 1. A device for sealing an opening in the wall of a bloodvessel, the blood vessel having an interior wall surface, exterior wallsurface, and a lumen, the device comprising: an automatic mechanism; ashaft extending between a proximal end and a distal end, the shaft beingfixedly connected to the automatic mechanism; a seal assembly having afirst portion and a second portion, the seal assembly operativelyattached at the first portion to the distal end of the shaft, the sealassembly configured to engage the interior wall surface and the exteriorwall surface of the blood vessel; and a pushing rod operatively engagingthe seal assembly at the second portion and movable relative to theshaft, the automatic mechanism moving the pushing rod from a firstposition to a second position in response to the shaft being pulleddistally a predetermined distance.
 2. The device for sealing an openingaccording to claim 1, wherein the shaft has a plurality of equallyspaced projections along a length thereof and a reduced portion, thereduced portion having a cross section being smaller than a crosssection of any other portion of the shaft.
 3. The device for sealing anopening according to claim 1, further comprising a safety latch, thesafety latch movable between a first position and a second position, thesafety latch engaging a pusher of the automatic mechanism in the firstposition thereby preventing the pusher from moving the pushing rod. 4.The device for sealing an opening according to claim 1, the devicefurther comprising a latch to engage an outer portion of cannula,through which the shaft, seal assembly, and the pushing rod pass forinsertion into a blood vessel.
 5. The device for sealing an openingaccording to claim 1, wherein the automatic mechanism further comprisesa pusher, the pusher moving the pushing rod from a first position to asecond position in response to the shaft being pulled distally apredetermined distance.
 6. The device for sealing an opening accordingto claim 1, wherein the automatic mechanism further comprises a shaftretaining element, the shaft being fixedly attached to the shaftretaining element.
 7. The device for sealing an opening according toclaim 1, the automatic mechanism comprising: a shaft retaining elementfixedly attached to the shaft; a pusher, the pusher fixedly attached tothe pushing rod; a spring; a spring retainer, the spring biased againstat least one surface of the spring retainer; and at least one retentionelement rotatably movable between a first and second position, the atleast one retention element disposed adjacent the spring retainer andengages the spring retainer in the first position.
 8. The device forsealing an opening according to claim 7, wherein the pusher has an upperportion and a lower portion, the upper and lower portions defining anopening therebetween, the shaft retaining element disposed in theopening between the upper and lower portions.
 9. The device for sealingan opening according to claim 7, wherein the pusher has an openingtherein, the shaft passing through the opening in the pusher.
 10. Thedevice for sealing an opening according to claim 7, wherein the pusherhas an opening therein, a proximal end of the pushing rod disposedwithin the opening in the pusher.
 11. The device for sealing an openingaccording to claim 7, wherein the at least one retention element engagesthe spring retainer and the shaft retaining element in the firstposition.
 12. The device for sealing an opening according to claim 7,wherein during operation, the shaft pulls the shaft retaining elementdistally, allowing the spring retainer to rotate the at least oneretaining element and engage the pusher to move the pusher distally. 13.A device for sealing an opening in the wall of a blood vessel, the bloodvessel having an interior wall surface, exterior wall surface, and alumen, the device comprising: an automatic mechanism comprising a shaftretaining element, a pusher, a spring retainer, a spring biased againstat least one surface of the spring retainer, at least one retentionelement rotatably movable between a first and second position, the atleast one retention element disposed adjacent the spring retainer andengages the spring retainer in the first position; a shaft extendingbetween a proximal end and a distal end, the shaft being fixedlyconnected to the shaft retaining element; a seal assembly having a firstportion and a second portion, the seal assembly operatively attached atthe first portion to the distal end of the shaft, the seal assemblyconfigured to engage the interior wall surface and the exterior wallsurface of the blood vessel; and a pushing rod fixedly attached to thepusher and movable relative to the shaft, the pushing rod operativelyengaging the seal assembly at the second portion, the pusher moving thepushing rod from a first position to a second position in response tothe shaft being pulled distally a predetermined distance.
 14. A methodof sealing an opening in the wall of a blood vessel, the blood vesselhaving an interior wall surface, exterior wall surface, and a lumen, themethod comprising: inserting at least a portion of a distal end of anautomatic device through the opening and into the lumen, the distal endhaving a seal assembly that includes a first sealing element disposed inthe lumen of the blood vessel and configured to engage the interior wallsurface and a second sealing element to engage the exterior wallsurface, pulling proximally on the automatic device, causing the firstsealing element to engage the interior wall surface and pull on a shaftconnected to the seal assembly, thereby causing the automatic device toautomatically push the second sealing element against the exterior wallsurface sealing the opening in the wall of the blood vessel; andremoving automatic device leaving only the seal assembly behind.
 15. Themethod according to claim 14, wherein the seal assembly also includes anouter floating element disposed between the first and second sealingassemblies, the outer floating element engaging the exterior wallsurface and the second sealing element engaging the outer floatingelement.
 16. The method according to claim 14, the seal assembly furtherincludes a shaft, the shaft being integral with the first sealingelement and the second sealing element slides along at least a portionof the shaft to engage the exterior wall surface.
 17. The methodaccording to claim 16, wherein the shaft breaks at a predetermined pointafter the second sealing element stops being pushed along the shaft. 18.The method according to claim 14, wherein the automatic device isinserted into the blood vessel through a cannula.